Description

Naldemedine CAS NO 916072-89-4 is a highly selective peripherally-acting opioid receptor antagonist (PAMORA). This compound is of significant commercial and therapeutic importance as it is specifically designed to block the constipating effects of opioids in the gastrointestinal tract without interfering with their central analgesic benefits. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for opioid-induced constipation (OIC) and related gastrointestinal disorders.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of prescription medications for opioid-induced constipation (OIC).
• Key intermediate in advanced pharmaceutical research and development of novel peripheral opioid antagonists.
• Reference standard for quality control and analytical testing in pharmaceutical laboratories.
• Biochemical research tool for studying peripheral opioid receptor mechanisms and gastrointestinal motility.
• Formulation development for solid oral dosage forms such as tablets and capsules.
• Preclinical and clinical trial material for investigational new drug (IND) applications.

Basic Information

Item	Details
Product Name	Naldemedine
CAS No.	916072-89-4
Molecular Formula	C32H34N4O6
Molecular Weight	570.64 g/mol
Synonyms	Naldemedine Tosylate; S-297995; LY-2456302; (3R)-3-({[(1S)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy}carbonyl)amino)-8-{[(2R)-2-(3,5-dimethyl-1H-1,2,4-triazol-1-yl)-1-pyrrolidinyl]carbonyl}-2,8-diazaspiro[4.5]decan-1-one; Opioid Receptor Antagonist LY-2456302
EINECS	Contact for details

Quality Control

Our Naldemedine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent pharmaceutical-grade specifications, including identity, purity, and impurity profile verification. Certificates of Analysis (COA) detailing results from HPLC, NMR, and MS are available upon request to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.